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Biopharmaceutical
Royalty Rates Analysis:
Essential Benchmarks for Dealmaking
BioWorld Data
                         Biopharmaceutical Royalty Rates Analysis:
                           Essential Benchmarks for Dealmaking




Executives involved in any aspect of dealmaking know it’s hard to find real-world data on deal
terms such as royalty rates, milestones and up-fronts. A new tool from BioWorld solves this
problem. Biopharmaceutical Royalty Rates Analysis: Essential Benchmarks for Dealmaking
analyzes hundreds of licensing deals to provide a tangible starting point for smart dealmaking.

In addition to sector-wide analyses, which provide an array of average and median royalty rates
and up-front licensing fees, the report takes a deeper dive into these hot disease areas:
Alzheimer’s, cancer, cardiovascular, diabetes, hepatitis and pain management. Backing up the
analyses are profiles of more than 320 deals including not only the royalty rates, but all deal
terms and key background information on the drug or drug technology in focus – invaluable
details to be used as benchmarks and comparators when crafting new licensing deals.

                             IP Asset Payout Information is Critical:
* The tough economy has forced drug makers to sharpen dealmaking skills. Without the
opportunity for investors to cash out in normal cycles, deals are more important than ever.
* There’s a trend now to do bigger deals earlier in the game. Preclinical pacts aren’t
uncommon.
* An increase in dealmaking also results in an increase in deal terminations when big pharmas
restructure pipelines or when trials don’t produce expected results. Ironclad contracts protect
both parties.
* The dealmaking trend is likely to continue because big pharma has reached the dreaded patent
cliffs.
* Life science attorneys need these data points, too, as part of patent valuation and to establish
infringement litigation damages.

   Don’t get caught at the negotiating table without critical deal terms to justify proposals.

       Available in digital reader edition available with interactive point & click features.
                      For Special Introductory Rates Call 1-800-888-3912
Table of Contents

                                                             Table of Contents

Bird’s-Eye View............................................................................................................................... 13
A Tangible Starting Point for Smart Dealmaking ............................................................................14

A Deep Dive..................................................................................................................................... 16
Vital Statistics...................................................................................................................................17
Make a Big Deal of Taking the Royalty Road..................................................................................18
Alzheimer’s Royalty Rates...............................................................................................................26
Cancer Royalty Rates. ......................................................................................................................27
                            .
Cardiovascular Royalty Rates...........................................................................................................30
Diabetes Royalty Rates.....................................................................................................................32
Hepatitis Royalty Rates....................................................................................................................33
                               .
Pain Royalty Rates............................................................................................................................34
Royalty Rates for Biopharmaceutical Companies............................................................................35

The Deal Details.............................................................................................................................. 46

Autoimmune.................................................................................................................................... 47
BB-882 - Asthma..............................................................................................................................48
Copaxone - Multiple Sclerosis..........................................................................................................49
Drugs for Arthritis and Pneumocystis carinii pneumonia.................................................................51
Humanized Monoclonal Antibody....................................................................................................52
Humira - Rheumatoid Arthritis.........................................................................................................54
Indaflex - Arthritis.............................................................................................................................56
Primatized Anti-CD4 Antibodies - Rheumatoid Arthritis.................................................................58
Primatized Anti-CD4 Antibodies - Allergies....................................................................................59
R788 - Rheumatoid Arthritis............................................................................................................60
                                     .

Cancer.............................................................................................................................................. 62
2-deoxy-d-glucose - Cancer..............................................................................................................63
AastromReplicell - Cancer. ..............................................................................................................65
                                     .
Acadesine - B-cell Chronic Lymphocytic Leukemia........................................................................67
AGT 203 - Cancer, Age-Related Degeneration, Diabetes, Obesity..................................................68
AL6082 - Cancer..............................................................................................................................69
                      .
Anticancer Immunity Treatment - Cancer........................................................................................70
Atiprimod - Cancer...........................................................................................................................71
Avicine - Multiple Cancer Indications..............................................................................................72
Bisanthracyclines - Tumors..............................................................................................................74
                                      .
Cancer Drug......................................................................................................................................75
Cancer Drug......................................................................................................................................76
Cancer Drug......................................................................................................................................77
Cancer Drug......................................................................................................................................78
Cancer Therapy - Delivery...............................................................................................................79
                                     .
Cancer Therapy - Metastatic Melanoma...........................................................................................80
Ceplene - Leukemia..........................................................................................................................81
Cintredekin Besudotox - Cancer.......................................................................................................83

Essential Benchmarks for Dealmaking	                                                                                                                         5
Table of Contents

Clolar - Hematological Malignancies...............................................................................................84
CRx-026 - Multiple Tumor Types. ...................................................................................................86
                                             .
Combined Immunogene Therapy - Cancer.......................................................................................88
CTCE-9908, CTCE-0214 - Cancer, Transplant................................................................................89
Dacogen - Cancer. ............................................................................................................................90
                    .
Dibromodulcitol (DBD) - Cancer.....................................................................................................93
Disodium Clodronate - Cancer-Associated Bone Diseases..............................................................94
Electrostatic Liposome - Cancer Drug Delivery. .............................................................................96
                                                                   .
Erbitux - Colorectal Cancer..............................................................................................................98
Erivedge (GDC-0449) - Cancer......................................................................................................100
Eylea - Cancer.................................................................................................................................103
GCS-100 - Colorectal and Pancreatic Cancers...............................................................................106
Genasense - Cancer.........................................................................................................................107
Hematology Controls Using Reticulocytes. ...................................................................................108
                                                           .
Histone Deacetylase (HDAC) Inhibitors - Multiple Cancer Indications........................................109
huN901-DM1 (IMGN901) Tumor-Activated ................................................................................ 111
Prodrug - Small-Cell Lung Cancer................................................................................................. 111
Intron A - Cancer, Infection............................................................................................................ 113
Listeria Monocytogenes-Based Vaccine - Various Cancer Indications.......................................... 114
Mammary Cell Growth Inhibitor Protein....................................................................................... 116
Monoclonal Antibody Technology................................................................................................. 117
                                              .
MP-470 - Small Cell Lung Cancer................................................................................................. 119
MuGard - Cancer............................................................................................................................120
Multikine - Cancer..........................................................................................................................122
Naked DNA Technology - Cancer..................................................................................................123
Nano Curcumin . ............................................................................................................................125
Nexavar - Cancer............................................................................................................................127
NOV-002/NOV-205 - Cancer, Infection.........................................................................................128
NV-128 - Cancer.............................................................................................................................129
Nuclear Matrix Protein Technology. ..............................................................................................130
                                                .
Oncaspar - Cancer...........................................................................................................................131
Oncolym - Hodgkin’s B-cell Lymphoma. ......................................................................................132
                                                        .
Oncolysin B - B-cell Lymphoma....................................................................................................134
Optisome Nanoparticle Technology - Drug Delivery Technology.................................................136
Optisome Nanoparticle Technology - Drug Delivery Technology.................................................139
Oxygen Enhancement Technology for Chemotherapeutics - Various Cancers..............................141
Phenoxodiol - Cancer. ....................................................................................................................143
                          .
Phosphatases - Glioblastomas.........................................................................................................145
Picoplatin - Small-Cell Lung Cancer..............................................................................................146
Picoplatin - Small-Cell Lung Cancer..............................................................................................148
Platinate HPMA Copolymer - Cancer............................................................................................152
                                                   .
Radinyl - Cancer.............................................................................................................................153
RAS Human Protein/Rational Drug Design - Malignant Tumors..................................................154
Recombinant Human Interleukin-12..............................................................................................155
                                                 .
Retinoids - Kidney Cancer, Leukemia............................................................................................156
Rhenium Radiotherapy and Monoclonal Antibodies - Colon Cancer............................................158
RSR13 - Cancer..............................................................................................................................160

6	         	          	          	          	          	                 BioWorld Data: Biopharmaceutical Royalty Rates Analysis
Table of Contents

Satraplatin - Prostate Cancer. .........................................................................................................161
                                    .
Satraplatin - Cancer........................................................................................................................162
                      .
Specific Drug Undisclosed - Various Cancer Therapies.................................................................163
Stem Cell Proliferation Factor - Cancer.........................................................................................164
                                                     .
TAP Technology - Cancer...............................................................................................................165
Tarceva - Cancer.............................................................................................................................167
Tarceva - Various Cancer Indications.............................................................................................169
Thalidomide Analogues - Cancer...................................................................................................171
                                           .
Thalomid - Multiple Myeloma.......................................................................................................173
                                       .
Theragyn - Ovarian Cancer. ...........................................................................................................175
                                  .
Tissue Malignancy Treatments - Cancer. .......................................................................................176
                                                       .
Vectibix - Colorectal Cancer...........................................................................................................177
Xerecept - Brain Tumors................................................................................................................181
                              .
Zaltrap - Cancer..............................................................................................................................183

Cardiovascular.............................................................................................................................. 185
Adenocard - Paroxysmal Supraventricular Tachycardia. ...............................................................186
                                                                                   .
Aggrastat (tirofiban hydrochloride) - Acute Coronary Syndrome..................................................187
Angiogenix - Cardiovascular..........................................................................................................191
Angiomax - Cardiovascular............................................................................................................192
Anti-hypertension Therapy.............................................................................................................193
Autologous Gene Therapy - Hypertension.....................................................................................194
BAY 59-7939 - Cardiovascular. .....................................................................................................195
                                             .
Bextra - Congestive Heart Failure..................................................................................................196
Bystolic - Hypertension..................................................................................................................197
Cardio Vascu-Grow - Cardiovascular.............................................................................................199
Cardiovascular Drug.......................................................................................................................200
Cardiovascular Drug.......................................................................................................................201
Cardiovascular Drug.......................................................................................................................202
CMI-121 - Cardiovascular..............................................................................................................204
Elafin - Cardiovascular...................................................................................................................205
Esbriet - Fibrotic Disease................................................................................................................206
Fenoglide - Cardiovascular.............................................................................................................208
Fortamet, Altoprev - Cardiovascular..............................................................................................209
                                                     .
Gel Lock Invention and Taurolidine Treatments - Cardiorenal Disease. .......................................210
                                                                                                           .
Gencaro - Cardiovascular............................................................................................................... 211
Gencaro - Chronic Heart Failure....................................................................................................212
                                                .
HepArrest - Cardiovascular............................................................................................................213
Integrilin - Cardiovascular Disease. ...............................................................................................214
                                                   .
M-Enoxaparin - Cardiovascular. ....................................................................................................215
                                               .
MyoCell - Cardiovascular...............................................................................................................217
Naked DNA Technology - Cardiovascular Disease........................................................................219
Non-PESDA Microbubbles - Cardiovascular.................................................................................221
Paclitaxel.........................................................................................................................................222
Paclitaxel Technology - Cardiovascular.........................................................................................222
Portable Ultrasonic Nebulizer - Cardiovascular Disease................................................................223
Pro-Apolipoprotein A-I - Cardiovascular.......................................................................................224

Essential Benchmarks for Dealmaking	                                                                                                                        7
Table of Contents

Ranexa - Angina.............................................................................................................................225
                 .
Relovair - Chronic Obstructive Pulmonary Disease and Asthma...................................................228
RNAi Technologies - Respiratory Syncytial Virus.........................................................................230
Tadalafil - Hypertension. ................................................................................................................232
                           .
Teveten - Hypertension...................................................................................................................236
ThromboClear - Cardiovascular.....................................................................................................237
Tiazac - To Reduce the Risk of Heart Attacks................................................................................238

Central Nervous System...............................................................................................................239
Acurox - Abuse-Resistant Painkiller. .............................................................................................240
                                                  .
ALKS 33 - Alcohol Dependence....................................................................................................241
Alzheimer’s Drug - Alzheimer’s Disease.......................................................................................243
Alzheimer’s Drug - Alzheimer’s Disease.......................................................................................244
Alzheimer’s Drug - Alzheimer’s Disease.......................................................................................246
Alzheimer’s Drug - Alzheimer’s Disease.......................................................................................247
Ampligen - Chronic Fatigue Syndrome..........................................................................................248
Attention Deficit Hyperactivity Disorder Therapy.........................................................................250
Avinza - Pain...................................................................................................................................251
Avinza - Pain...................................................................................................................................253
Axokine/Pegylated Axokine - Obesity...........................................................................................255
                                                     .
AZ-004 - Schizophrenia or Bipolar Disorder.................................................................................256
Bicifadine - Dental Pain..................................................................................................................258
Brain-Derived Neurotrophic Factor................................................................................................261
Chronogesic - Pain..........................................................................................................................264
Dexfenfluramine - Obesity. ............................................................................................................265
                                   .
Doxylamine Succinate Nasal Spray - Sleep Therapy.....................................................................267
Entereg - Pain.................................................................................................................................269
               .
Estradot - Menopausal Symptoms..................................................................................................270
Fanapt - Schizophrenia...................................................................................................................272
Fanapt - Schizophrenia...................................................................................................................273
Fanapt - Schizophrenia...................................................................................................................274
Flexogan - Pain Management.........................................................................................................276
Frova - Menstrual Migraines..........................................................................................................277
Frova - Migraine Relief..................................................................................................................279
Gralise - Postherpetic Neuralgia.....................................................................................................281
Horizant - Pain................................................................................................................................282
Indiplon - Insomnia.........................................................................................................................284
Indiplon - Insomnia.........................................................................................................................287
Inflammation Antibody-based Therapeutics...................................................................................289
Ion Channel Modulators - Pain.......................................................................................................291
Ketoprofen - Inflammation.............................................................................................................292
Memryte - Alzheimer’s Disease.....................................................................................................293
                                           .
Memryte - Alzheimer’s Disease.....................................................................................................295
                                           .
Naked DNA Technology.................................................................................................................297
Neotrofin - Neuroimunologic Disorders.........................................................................................299
Nervous System Therapeutics........................................................................................................302
                                        .


8	         	          	          	          	          	                  BioWorld Data: Biopharmaceutical Royalty Rates Analysis
Table of Contents


NeuroCell - Parkinson’s and Huntington’s diseases.......................................................................304
Neuroimmunophilins - Nerve Repair.............................................................................................307
                                                   .
Neurological Peptide Therapy........................................................................................................309
Neurological Therapeutics.............................................................................................................. 311
NGD 94-1 - Schizophrenia.............................................................................................................312
NicVAX - Smoking Cessation........................................................................................................313
Novantrone - Multiple Sclerosis.....................................................................................................316
NRP104 - Attention Deficit Hyperactivity Disorder. .....................................................................320
                                                                          .
Opana - Pain...................................................................................................................................323
              .
Oral Flupirtine - Fibromyalgia........................................................................................................325
Oruvail - Pain..................................................................................................................................326
Pain Management...........................................................................................................................327
                     .
Phospholipids - Central Nervous System Conditions.....................................................................328
Posidur - Postsurgical Pain.............................................................................................................329
PQ-1002 - Anesthesia.....................................................................................................................331
Remoxy - Pain................................................................................................................................332
                .
Risperdal Consta - Schizophrenia and Bipolar Disorder................................................................333
Ryzolt - Pain...................................................................................................................................335
              .
Sarafem - Premenstrual Syndrome.................................................................................................336
Transgenic Mouse Model - Alzheimer’s Disease...........................................................................340
Treximet - Migraine........................................................................................................................341
Vivitrol - Alcohol & Opioid Dependency.......................................................................................343
Zolpimist - Insomnia.......................................................................................................................345

Diabetes.......................................................................................................................................... 347
A-4166 - Diabetes...........................................................................................................................348
AERx - Diabetes.............................................................................................................................349
AGT 203 - Cancer, Age-Related Degeneration, Diabetes, Obesity................................................350
Bydureon - Diabetes.......................................................................................................................351
Bydureon - Type II Diabetes...........................................................................................................353
Development of Drugs - Type II Diabetes......................................................................................355
Diabetes Therapy............................................................................................................................356
Diabetes Therapy............................................................................................................................358
Fortamet - Type II Diabetes............................................................................................................359
Glumetza - Diabetes. ......................................................................................................................360
                           .
Luteolin - Diabetes. ........................................................................................................................361
                         .
SF-1019 - Diabetes.........................................................................................................................362

Infection......................................................................................................................................... 363
Alpha Interferon-Natural - Infection. .............................................................................................364
                                                     .
Alferon N Injection - Viral Diseases...............................................................................................367
AmBisome - Fungal Infections.......................................................................................................371
Antibody IFT - HIV........................................................................................................................372
BioNasal - Chronic Rhinosinusitis.................................................................................................373
BPI - Sepsis.....................................................................................................................................375
CY 1787 and CY 1503 - Septic Shock and Adult Respiratory Distress Syndrome........................379
Danoprevir (RG7227) - Hepatitis C. ..............................................................................................380
                                                   .

Essential Benchmarks for Dealmaking	                                                                                                                        9
Table of Contents


Erythromycin Antibiotic - Bacterial Infections..............................................................................383
                                                                  .
Fuzeon - HIV..................................................................................................................................384
Gene Therapy Products - Hepatitis B and C...................................................................................386
HE317 - Immunodeficiencies.........................................................................................................387
Hepatitis and Retrovirus Technologies - Hepatitis G.....................................................................388
                                                                           .
Hepatitis A Vaccine.........................................................................................................................389
Hepatitis B Drug - Infection...........................................................................................................390
Hepatitis B Drug.............................................................................................................................391
Hepatitis C Vaccine.........................................................................................................................392
Hepatitis E Vaccine.........................................................................................................................393
HepeX-B - Hepatitis B....................................................................................................................394
Heplisav - Infection........................................................................................................................395
                        .
HIV and Hepatitis Vaccines............................................................................................................396
HIV/AIDS Vaccine.........................................................................................................................398
HIV Drug........................................................................................................................................402
HIV Drugs. .....................................................................................................................................403
           .
Iminosugars - Potential Antiviral....................................................................................................405
Incivek - Hepatitis C.......................................................................................................................406
Infergen - Hepatitis C.....................................................................................................................408
                           .
Interferon-g - HIV...........................................................................................................................412
Method for Interferon - Hepatitis B and C infection......................................................................414
Monoclonal Antibodies - Gram-Negative Sepsis-Related Bacteria...............................................416
                                                                                                 .
Naked DNA Technology.................................................................................................................419
Nanocrystalline Particles................................................................................................................421
NCX 1000 - Hepatitis C and Hypertension....................................................................................422
Novasome Lipid Vesicles Encapsulation Technology - Vaccines...................................................424
Omniferon - Hepatitis C.................................................................................................................425
                               .
Oragen - HIV..................................................................................................................................428
Protease Inhibitors - HIV and AIDS...............................................................................................430
Questcor Patents – Hepatitis C.......................................................................................................432
Relenza - Influenza.........................................................................................................................434
Ribozymes - HIV............................................................................................................................436
S-1153 - HIV...................................................................................................................................438
Small Molecules - Hepatitis C........................................................................................................440
Tamiflu - Influenza..........................................................................................................................442
Taribavirin - Hepatitis C.................................................................................................................445
Technologies and Product Candidates - Hepatitis C.......................................................................448
Tyzeka/Sebivo - Hepatitis B...........................................................................................................449
Vaccines, Gene-Based - HIV, Hepatitis B & C Viruses, Herpes, . .................................................451
Papilloma, Measles, Tuberculosis and Influenza............................................................................451
Vaccine Research - HIV, Hepatitis, Influenza.................................................................................453
Vibativ - Gram-Positive Infections.................................................................................................454
Viread - HIV...................................................................................................................................455
Viread and Preveon - HIV..............................................................................................................458
                                  .
Virus-like Particle Vaccines - Human Papillomavirus....................................................................462
Zadaxin - Hepatitis C......................................................................................................................464


10	        	          	          	          	          	                  BioWorld Data: Biopharmaceutical Royalty Rates Analysis
Table of Contents


Miscellaneous................................................................................................................................ 466
               .
A1PI - Alpha-1 antitrypsin deficiency............................................................................................467
Actimmune - Infections, Pulmonary Fibrosis and Cancer..............................................................469
Aldurazyme - Mucopolysaccharidosis I.........................................................................................471
Alpha Interferon..............................................................................................................................473
Auriculin Anaritide - Acute Renal Failure......................................................................................475
Bio-Equivalent Cardizem CD ........................................................................................................477
Cochleates, Liposomes and Proteoliposomes.................................................................................478
Collagenase Ointment - Dermal Ulcers and Burns.........................................................................484
Combinatorial Chemistry Services - Drug Discovery....................................................................485
CY 1787 and CY 1503 - Septic Shock and Adult Respiratory Distress Syndrome........................486
Cytofectins - Cystic Fibrosis..........................................................................................................488
                                    .
Dermagran II Ointment and Spray - Wound Healing.....................................................................490
Estrasorb - Estrogen Therapy.........................................................................................................491
                                      .
Gattex - Gastrointestinal Disorders. ...............................................................................................494
                                              .
Gene Therapy Partnership Network...............................................................................................496
                                                .
Gene Therapy Treatments...............................................................................................................497
Genentech Products........................................................................................................................499
Hectorol - Osteoporosis..................................................................................................................504
Hextend and PentaLyte - Hypovolemia..........................................................................................507
Hextend and PentaLyte - Hypovolemia..........................................................................................509
Hextend - Hypovolemia.................................................................................................................. 511
Hextend - Hypovolemia..................................................................................................................513
Human Growth Hormone...............................................................................................................515
Humanized Antibody......................................................................................................................516
IgA Nephropathy Treatment...........................................................................................................518
IMOs - Allergy................................................................................................................................520
Indaflex and Flexogan - Inflammatory. ..........................................................................................522
                                                   .
Kuvan, PEG-PAL, 6R-BH4 - Phenylketonuria and Cardiovascular. .............................................524
                                                                                                .
Living Cells Connective Tissue......................................................................................................526
Loteprednol Etabonate - Ophthalmic..............................................................................................527
Lubrin - Vaginal Dryness................................................................................................................528
M-Enoxaparin.................................................................................................................................529
MDX-RA - Secondary Cataracts....................................................................................................530
Monoclonal Antibodies Binding to TGF-B....................................................................................534
Neupogen - Anemia........................................................................................................................536
Oral Contraceptives........................................................................................................................539
Prochieve - Preterm Birth...............................................................................................................540
Procrit - Anemia..............................................................................................................................541
Receptor-Mediated Permeabilizers.................................................................................................545
RNA Interference Technology........................................................................................................547
RNA Interference Technology........................................................................................................550
Sexual Dysfunction Therapy..........................................................................................................554
                                    .
Solaraze and Others - Dermatology................................................................................................555
Systemic Evolution of Ligands through EXponential Enrichment (SELEX) - Oligonucleotides
Screening Process...........................................................................................................................557
TGF-beta - Ophthalmological, Wounds, Autoimmune...................................................................560

Essential Benchmarks for Dealmaking	                                                                                                                11
Table of Contents


Thymosin Beta 4 - Various Indications. .........................................................................................565
                                     .
Vaniqa - Excessive Facial Hair on Women.....................................................................................567

Technology..................................................................................................................................... 570
ACTCellerate - Embryonic Stem Cell Technology........................................................................571
Bioadhesive Delivery System - Drug Delivery..............................................................................573
Cell Culture Flask Patent................................................................................................................574
Cochleate Technology.....................................................................................................................576
Cypress Stem Cells.........................................................................................................................580
DNA Nanocircles - Research..........................................................................................................581
Duros Drug Delivery Technology...................................................................................................582
Gene Alteration Technology...........................................................................................................585
Gene Sequencing Technology - Infectious Diseases......................................................................586
Genetically Engineered Listeria Immune Therapy.........................................................................588
Heat-Activated Gene Therapy Technology - Cancer......................................................................591
hESC Technology - Technology.....................................................................................................593
HuMAb-Mouse Technology...........................................................................................................595
Mammalian Embryonic Stem Cells Technology............................................................................599
Method for Binding DNA and RNA...............................................................................................601
Naked DNA Technology.................................................................................................................602
NASA Technology..........................................................................................................................604
Natural Cell Signaling Technologies..............................................................................................605
Nebulizer - Technology. .................................................................................................................607
                             .
NTP Testing Technology - Technology..........................................................................................608
                                                     .
Nucleoside Technology - Hepatitis B.............................................................................................609
Optison - Contrast Agent................................................................................................................610
PharmaPrint Process - Drug Development, Botanicals..................................................................612
ppGpp Degradase and Peptide Deformylase Technology..............................................................613
                                                                                 .
Stem Cell Lines...............................................................................................................................614
Stem Cell Technology.....................................................................................................................615
Stem-Loop Vector Technology ......................................................................................................616
Thrombus Ligands - Diagnostic Imaging.......................................................................................617
Thymidine Kinase Isoenzyme Diagnostics and Thymidine Kinase Hybridomas..........................619
UMASS Patents - Cartilage Regenerative Technology..................................................................620
VelocImmune Technology..............................................................................................................621
XenoMouse Technology - Cancer..................................................................................................623
                                             .

Indices............................................................................................................................................ 624
Companies and Other Organizations Index....................................................................................625
Inventors Index...............................................................................................................................631
Drugs and Therapeutic Technologies Index...................................................................................632
                                                                .
Diseases, Indications and Targets Index.........................................................................................636




12	        	          	           	          	           	                  BioWorld Data: Biopharmaceutical Royalty Rates Analysis
Cancer


                                   Picoplatin - Small-Cell Lung Cancer
 Licensor                  Genzyme Corp.
 Licensee                  Poniard Pharmaceuticals Inc.
 Royalty/Deal Value        $11 million cash plus $1 million of common stock plus 9% of sales
 Drug/Product Name         Picoplatin
 Type/Product Area         License agreement for worldwide rights
 Terms/Details             $11 million cash plus $1 million of common stock plus 9% of sales
 Date                      2004

                                                  Deal Summary

Poniard holds an exclusive worldwide license granted from Genzyme Corp. for the development and commercial
sale of picoplatin. Under the license agreement, as amended, Genzyme retains the right to prosecute its patent ap-
plications and maintain all licensed patents, with Poniard reimbursing such expenses. Poniard has the right to sue
any third party infringers of the picoplatin patents. If Poniard does not file suit, Genzyme, in its sole discretion,
has the right to sue the infringer at its expense.

The parties executed the license agreement in April 2004, at which time Poniard paid a one-time upfront mile-
stone payment of $1 million in common stock and $1 million in cash. The original license agreement excluded
Japan from the licensed territory and provided for $13 million in development and commercialization milestones,
payable in cash or a combination of cash and common stock, and a royalty rate of up to 15% of product net sales
after regulatory approval. The parties amended the license agreement on Sept. 18, 2006, modifying several key
financial terms and expanded the licensed territory to include Japan, thereby providing Poniard worldwide rights.
In consideration of the amendment, Poniard paid Genzyme $5 million in cash on Oct. 12, 2006 and paid Genzyme
an additional $5 million in cash on March 30, 2007. The amendment eliminated all development milestone pay-
ments to Genzyme. Poniard remains obligated to pay a total of $5 million in commercialization milestones upon
the attainment of certain levels of annual net sales of picoplatin after regulatory approval. The amendment also
reduced the royalty payable to Genzyme to a maximum of 9% of annual net product sales and eliminated sharing
of sublicense revenues with Genzyme. The license agreement may be terminated by either party for breach, or
if the other party files a petition in bankruptcy or insolvency or for reorganization or is dissolved, liquidated or
makes assignment for the benefit of creditors. Poniard can terminate the license at any time upon prior written
notice to Genzyme. If not earlier terminated, the license agreement will continue in effect, in each country in the
territory in which the licensed product is sold or manufactured, until the earlier of (i) expiration of the last valid
claim of a pending or issued patent covering the licensed product in that country or (ii) a specified number of years
after first commercial sale of the licensed product in that country.

Poniard’s picoplatin portfolio includes U.S. and foreign patents and applications licensed from Genzyme, which
cover the picoplatin product. With respect to picoplatin, Poniard expected to rely primarily on U.S. Patent No.
5,665,771 (expiring Feb. 7, 2016), which is licensed to it by Genzyme, and additional licensed patents expiring in
2016 covering picoplatin in the European Union and other countries.




148	    	      	       	       	       	            BioWorld Data: Biopharmaceutical Royalty Rates Analysis
Cancer

Picoplatin
Drug Description/      Picoplatin is an intravenous platinum-based chemotherapeutic designed to treat sol-
Mechanism              id tumors that are resistant to existing platinum-based cancer therapies.
Drug History           The FDA designated picoplatin as an orphan drug for the treatment of small cell lung
                       cancer and the European Commission designated picoplatin as an orphan medicinal
                       product for the treatment of small cell lung cancer in the European Union, which en-
                       titles Poniard to exclusive marketing rights for picoplatin in the European Union for
                       ten years following market approval.
                       In 2010, Poniard decided to suspend efforts to obtain regulatory approval of pico-
                       platin after a detailed analysis primary and updated data from the Phase III study of
                       picoplatin in small-cell lung cancer (SCLC) and an evaluation of the ongoing new drug
                       application process with the FDA. The company said it has engaged Leerink Swann
                       LLC to conduct a comprehensive review of strategic alternatives, which could include
                       capital raising alternatives, merger, sale or partnership. Poniard also announced a re-
                       structuring of its work force, eliminating about 45%, to a total of 12, effective April 30.
                       The company said it would focus its resources on developing pivotal clinical strate-
                       gies for picoplatin in small-cell lung cancer, as well as colorectal, prostate and ovarian
                       cancers.
                       Poniard executives blamed the failure of the highly anticipated SPEAR (Study of Pico-
                       platin Efficacy After Relapse) trial on an imbalance of third-line chemotherapy given
                       to patients in the best supportive care arm vs. the picoplatin arm.


                                               Genzyme Corp.
Company        Founded in June 1981 by Henry Blair and Sherry Snyder
History        Began operations by acquiring Whatman Biochemicals Ltd., UK
               Member--Biotechnology Industry Organization
               Founded 16 labs (1990)
               Formed Neozyme Corp. to fund development of programs (10/90)
               Formed Neozyme II to fund the research, development and clinical testing of biotherapeutic
               products for the treatment of cystic fibrosis (4/92)
               Subsidiary IG Laboratories Inc. purchased Genetic Design Inc., a privately held genetic testing
               company (6/92)
               Acquired phospholipid business of Enzymatix Ltd. (6/92)
               Acquired Medix Biotech Inc. (6/92)
               Acquired Vivigen Inc., in exchange for stock valued at $40M (11/92)
               Neozyme I buyback of four programs, $49M (12/92)
               Established Genzyme Transgenics (now GTC Biotherapeutics) for producing human biothera-
               peutic products in the milk of transgenic animals (2/93)
               Acquired diagnostic business Virotech System-Diagnostika GmbH (4/93)
               Acquired diagnostic business Omnia Res srl (5/93)
               Neozyme I buyback of two programs, $49M (12/93)
               Acquired Swiss pharmaceutical manufacturer, Sygena Ltd. (7/94)
               Subsidiary Genzyme Transgenics purchased TSI, a publicly held clinical testing and production
               company (10/94)

Essential Benchmarks for Dealmaking 	                                                                         149
Cancer

                  Created Genzyme Tissue Repair by acquiring BioSurface Technology Inc. and combining with
                  several of Genzyme Corp.’s tissue repair programs (12/94)
                  Acquired all shares of IG Laboratories Inc. (9/95)
                  Formed Aristogen GmbH with Symbiomed (Germany) to offer genetic diagnostic services in
                  Germany (3/96)
                  Acquired Genetrix Inc. (4/96)
                  Acquired Deknatel Snowden Pencer Inc., $250M (7/96)
                  Neozyme II Corp. buyback, $109M (9/96)
                  Formed Genzyme Molecular Oncology Division after acquisition of PharmaGenics Inc. (6/97)
                  Acquired ABIOMED Inc. for $15M (7/97)
                  Sold research products business to Techne Corp. for $65.5M (6/98)
                  Acquired GelTex Pharmaceuticals Inc. (12/00)
                  Acquired Novazyme Pharmaceuticals (9/01)
                  Ceased trading of Genzyme Biosurgery and Genzyme Molecular Oncology stock (7/03)
                  Acquired Sangstat Medical Corp. (12/03)
                  Acquired ILEX Oncology Inc. (12/04)
                  Acquired Verigen AG (2/05)
                  Acquired Bone Care International (7/05)
                  Acquired AAV gene therapy assets from Avigen Inc. (12/05)
                  Acquired AnorMED Inc. (11/06)
                  Acquired manufacturing equipment and other technology from Targeted Genetics Corp. for up
                  to $7M (2/10)
                  Sold Genzyme Genetics to Laboratory Corp. of America for $925M (9/10)
                  Sold its diagnostic products business to Sekisui Chemical Co. Ltd. For $265M (11/10)
                  Sold its enetics business unit to Laboratory Corp. of America (11/10)
                  Sold its pharmaceutical intermediates business to International Chemical Investors Group
                  (3/11)
                  Acquired by Sanofi-Aventis SA (4/11)


                               Genzyme Corp.: Additional Agreements
Partnered Company    Products Involved                                Agreement Type             Date
Algeta ASA           to study cancer targets using its Thorium plat- partnership                 4/11
                     form and Genzyme's tumor-targeting antibody
Angiotech Pharmaceu- identification, development and commercializa- strategic collab-            5/06
ticals Inc.          tion of therapies for cancer patients undergoing oration agree-
                     surgical removal of tumors                       ment
Arecor Ltd.          development of stable, high-strength formula- collaboration                 4/10
                     tions of labile biomolecules
De Novo Pharmaceuti- De Novo to apply its molecular structure gen- drug discovery                1/06
cals Ltd.            erating technology to focus on a disease target c o l l a b o r a t i o n
                     that is of interest to Genzyme                   agreement
ERYtech Pharma       therapeutic enzyme formulation for Genzyme d e v e l o p m e n t            10/10
                     disease indications using technology developed agreement
                     by ERYtech

150	   	      	        	      	      	           BioWorld Data: Biopharmaceutical Royalty Rates Analysis
Cancer

Hospira Worldwide Inc. to perform fill and finish manufacturing services material defini-    1/10
                       for Genzyme's Cerezyme, Fabrazyme, Myozyme tive agreement
                       and Thyrogen
Isis Pharmaceuticals   mipomersen                                        licensing     and   6/08
                                                                         collaboration
                                                                         agreement
Moffitt Cancer Center  diagnostic testing rights for two proteins for licensing agree-       1/08
                       NSCLC                                             ment
Oswaldo Cruz Founda- focus on neglected diseases, initially Chagas dis- research collabo-    7/07
tion                   ease                                              ration
PTC Therapeutics Inc.  PTC124                                            global develop-     7/08
                                                                         ment and com-
                                                                         mercialization
                                                                         agreement,
                                                                         rights returned
                                                                         to PTC (9/11)
To-BBB Technologies BV evaluation of G-Technology                        research collabo-   11/09
                                                                         ration
Veracyte Inc.          Veracyte's Afirma Thyroid FNA Analysis diagnos- global promo-         1/12
                       tic for thyroid cancer                            tion agreement




Essential Benchmarks for Dealmaking 	                                                                   151
Infection


                                         HepeX-B - Hepatitis B
Licensor                  XTL Biopharmaceuticals Ltd.
Licensee                  Cubist Pharmaceuticals Inc.
Royalty/Deal Value        $5 million plus 10% to 17% of sales
Drug/Product Name         HepeX-B
Type/Product Area         Cubist licensed worldwide rights to develop and commercialize the monoclonal anti-
                          body for hepatitis B
Terms/Details             XTL got $3 million in collaboration support and up-front payments and would be
                          entitled to another $3 million in milestones, plus royalties
Date                      June 2004


                                                Deal Summary

In June 2004, XTL granted worldwide rights to Cubist for the development and commercialization of an inves-
tigational monoclonal antibody known as HepeX-B, then in Phase IIb testing for the prevention of re-infection
by the hepatitis B virus in liver transplant patients. The companies agreed to continue the ongoing study and, if
successful, move into late-stage development. Cubist agreed to fund HepeX-B’s development costs and would
be responsible for worldwide registration and commercialization. It agreed to pay XTL collaboration support and
up-front payments totaling $3 million over the first two years and would owe an additional $3 million upon the
achievement of certain regulatory milestones. Cubist also committed to pay XTL a tiered royalty, ranging from
10% to 17% of net sales.

 HepeX-B
 Drug Description/        The drug is an antibody product designed to prevent re-infection by the hepatitis B
 Mechanism                virus in liver transplant patients.
 Drug History             HepeX-B demonstrated positive results in a Phase IIb study; however, meetings with
                          the FDA indicated that the regulatory pathway for the drug would pose operational
                          and economic challenges, and the companies decided to stop investing in the part-
                          nership in 2006.


                                         XTL Biopharmaceuticals Ltd.
Company           Founded in 1993
History
Business          Development, in-licensing, acquisition and commercialization of proprietary products and
Strategy          late-stage pharmaceutical product candidates for the treatment of unmet medical needs




394	   	      	       	       	      	            BioWorld Data: Biopharmaceutical Royalty Rates Analysis

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Biopharmaceutical Royalty Rates Analysis: Essential Benchmarks for Dealmaking (Preview)

  • 2. BioWorld Data Biopharmaceutical Royalty Rates Analysis: Essential Benchmarks for Dealmaking Executives involved in any aspect of dealmaking know it’s hard to find real-world data on deal terms such as royalty rates, milestones and up-fronts. A new tool from BioWorld solves this problem. Biopharmaceutical Royalty Rates Analysis: Essential Benchmarks for Dealmaking analyzes hundreds of licensing deals to provide a tangible starting point for smart dealmaking. In addition to sector-wide analyses, which provide an array of average and median royalty rates and up-front licensing fees, the report takes a deeper dive into these hot disease areas: Alzheimer’s, cancer, cardiovascular, diabetes, hepatitis and pain management. Backing up the analyses are profiles of more than 320 deals including not only the royalty rates, but all deal terms and key background information on the drug or drug technology in focus – invaluable details to be used as benchmarks and comparators when crafting new licensing deals. IP Asset Payout Information is Critical: * The tough economy has forced drug makers to sharpen dealmaking skills. Without the opportunity for investors to cash out in normal cycles, deals are more important than ever. * There’s a trend now to do bigger deals earlier in the game. Preclinical pacts aren’t uncommon. * An increase in dealmaking also results in an increase in deal terminations when big pharmas restructure pipelines or when trials don’t produce expected results. Ironclad contracts protect both parties. * The dealmaking trend is likely to continue because big pharma has reached the dreaded patent cliffs. * Life science attorneys need these data points, too, as part of patent valuation and to establish infringement litigation damages. Don’t get caught at the negotiating table without critical deal terms to justify proposals. Available in digital reader edition available with interactive point & click features. For Special Introductory Rates Call 1-800-888-3912
  • 3. Table of Contents Table of Contents Bird’s-Eye View............................................................................................................................... 13 A Tangible Starting Point for Smart Dealmaking ............................................................................14 A Deep Dive..................................................................................................................................... 16 Vital Statistics...................................................................................................................................17 Make a Big Deal of Taking the Royalty Road..................................................................................18 Alzheimer’s Royalty Rates...............................................................................................................26 Cancer Royalty Rates. ......................................................................................................................27 . Cardiovascular Royalty Rates...........................................................................................................30 Diabetes Royalty Rates.....................................................................................................................32 Hepatitis Royalty Rates....................................................................................................................33 . Pain Royalty Rates............................................................................................................................34 Royalty Rates for Biopharmaceutical Companies............................................................................35 The Deal Details.............................................................................................................................. 46 Autoimmune.................................................................................................................................... 47 BB-882 - Asthma..............................................................................................................................48 Copaxone - Multiple Sclerosis..........................................................................................................49 Drugs for Arthritis and Pneumocystis carinii pneumonia.................................................................51 Humanized Monoclonal Antibody....................................................................................................52 Humira - Rheumatoid Arthritis.........................................................................................................54 Indaflex - Arthritis.............................................................................................................................56 Primatized Anti-CD4 Antibodies - Rheumatoid Arthritis.................................................................58 Primatized Anti-CD4 Antibodies - Allergies....................................................................................59 R788 - Rheumatoid Arthritis............................................................................................................60 . Cancer.............................................................................................................................................. 62 2-deoxy-d-glucose - Cancer..............................................................................................................63 AastromReplicell - Cancer. ..............................................................................................................65 . Acadesine - B-cell Chronic Lymphocytic Leukemia........................................................................67 AGT 203 - Cancer, Age-Related Degeneration, Diabetes, Obesity..................................................68 AL6082 - Cancer..............................................................................................................................69 . Anticancer Immunity Treatment - Cancer........................................................................................70 Atiprimod - Cancer...........................................................................................................................71 Avicine - Multiple Cancer Indications..............................................................................................72 Bisanthracyclines - Tumors..............................................................................................................74 . Cancer Drug......................................................................................................................................75 Cancer Drug......................................................................................................................................76 Cancer Drug......................................................................................................................................77 Cancer Drug......................................................................................................................................78 Cancer Therapy - Delivery...............................................................................................................79 . Cancer Therapy - Metastatic Melanoma...........................................................................................80 Ceplene - Leukemia..........................................................................................................................81 Cintredekin Besudotox - Cancer.......................................................................................................83 Essential Benchmarks for Dealmaking 5
  • 4. Table of Contents Clolar - Hematological Malignancies...............................................................................................84 CRx-026 - Multiple Tumor Types. ...................................................................................................86 . Combined Immunogene Therapy - Cancer.......................................................................................88 CTCE-9908, CTCE-0214 - Cancer, Transplant................................................................................89 Dacogen - Cancer. ............................................................................................................................90 . Dibromodulcitol (DBD) - Cancer.....................................................................................................93 Disodium Clodronate - Cancer-Associated Bone Diseases..............................................................94 Electrostatic Liposome - Cancer Drug Delivery. .............................................................................96 . Erbitux - Colorectal Cancer..............................................................................................................98 Erivedge (GDC-0449) - Cancer......................................................................................................100 Eylea - Cancer.................................................................................................................................103 GCS-100 - Colorectal and Pancreatic Cancers...............................................................................106 Genasense - Cancer.........................................................................................................................107 Hematology Controls Using Reticulocytes. ...................................................................................108 . Histone Deacetylase (HDAC) Inhibitors - Multiple Cancer Indications........................................109 huN901-DM1 (IMGN901) Tumor-Activated ................................................................................ 111 Prodrug - Small-Cell Lung Cancer................................................................................................. 111 Intron A - Cancer, Infection............................................................................................................ 113 Listeria Monocytogenes-Based Vaccine - Various Cancer Indications.......................................... 114 Mammary Cell Growth Inhibitor Protein....................................................................................... 116 Monoclonal Antibody Technology................................................................................................. 117 . MP-470 - Small Cell Lung Cancer................................................................................................. 119 MuGard - Cancer............................................................................................................................120 Multikine - Cancer..........................................................................................................................122 Naked DNA Technology - Cancer..................................................................................................123 Nano Curcumin . ............................................................................................................................125 Nexavar - Cancer............................................................................................................................127 NOV-002/NOV-205 - Cancer, Infection.........................................................................................128 NV-128 - Cancer.............................................................................................................................129 Nuclear Matrix Protein Technology. ..............................................................................................130 . Oncaspar - Cancer...........................................................................................................................131 Oncolym - Hodgkin’s B-cell Lymphoma. ......................................................................................132 . Oncolysin B - B-cell Lymphoma....................................................................................................134 Optisome Nanoparticle Technology - Drug Delivery Technology.................................................136 Optisome Nanoparticle Technology - Drug Delivery Technology.................................................139 Oxygen Enhancement Technology for Chemotherapeutics - Various Cancers..............................141 Phenoxodiol - Cancer. ....................................................................................................................143 . Phosphatases - Glioblastomas.........................................................................................................145 Picoplatin - Small-Cell Lung Cancer..............................................................................................146 Picoplatin - Small-Cell Lung Cancer..............................................................................................148 Platinate HPMA Copolymer - Cancer............................................................................................152 . Radinyl - Cancer.............................................................................................................................153 RAS Human Protein/Rational Drug Design - Malignant Tumors..................................................154 Recombinant Human Interleukin-12..............................................................................................155 . Retinoids - Kidney Cancer, Leukemia............................................................................................156 Rhenium Radiotherapy and Monoclonal Antibodies - Colon Cancer............................................158 RSR13 - Cancer..............................................................................................................................160 6 BioWorld Data: Biopharmaceutical Royalty Rates Analysis
  • 5. Table of Contents Satraplatin - Prostate Cancer. .........................................................................................................161 . Satraplatin - Cancer........................................................................................................................162 . Specific Drug Undisclosed - Various Cancer Therapies.................................................................163 Stem Cell Proliferation Factor - Cancer.........................................................................................164 . TAP Technology - Cancer...............................................................................................................165 Tarceva - Cancer.............................................................................................................................167 Tarceva - Various Cancer Indications.............................................................................................169 Thalidomide Analogues - Cancer...................................................................................................171 . Thalomid - Multiple Myeloma.......................................................................................................173 . Theragyn - Ovarian Cancer. ...........................................................................................................175 . Tissue Malignancy Treatments - Cancer. .......................................................................................176 . Vectibix - Colorectal Cancer...........................................................................................................177 Xerecept - Brain Tumors................................................................................................................181 . Zaltrap - Cancer..............................................................................................................................183 Cardiovascular.............................................................................................................................. 185 Adenocard - Paroxysmal Supraventricular Tachycardia. ...............................................................186 . Aggrastat (tirofiban hydrochloride) - Acute Coronary Syndrome..................................................187 Angiogenix - Cardiovascular..........................................................................................................191 Angiomax - Cardiovascular............................................................................................................192 Anti-hypertension Therapy.............................................................................................................193 Autologous Gene Therapy - Hypertension.....................................................................................194 BAY 59-7939 - Cardiovascular. .....................................................................................................195 . Bextra - Congestive Heart Failure..................................................................................................196 Bystolic - Hypertension..................................................................................................................197 Cardio Vascu-Grow - Cardiovascular.............................................................................................199 Cardiovascular Drug.......................................................................................................................200 Cardiovascular Drug.......................................................................................................................201 Cardiovascular Drug.......................................................................................................................202 CMI-121 - Cardiovascular..............................................................................................................204 Elafin - Cardiovascular...................................................................................................................205 Esbriet - Fibrotic Disease................................................................................................................206 Fenoglide - Cardiovascular.............................................................................................................208 Fortamet, Altoprev - Cardiovascular..............................................................................................209 . Gel Lock Invention and Taurolidine Treatments - Cardiorenal Disease. .......................................210 . Gencaro - Cardiovascular............................................................................................................... 211 Gencaro - Chronic Heart Failure....................................................................................................212 . HepArrest - Cardiovascular............................................................................................................213 Integrilin - Cardiovascular Disease. ...............................................................................................214 . M-Enoxaparin - Cardiovascular. ....................................................................................................215 . MyoCell - Cardiovascular...............................................................................................................217 Naked DNA Technology - Cardiovascular Disease........................................................................219 Non-PESDA Microbubbles - Cardiovascular.................................................................................221 Paclitaxel.........................................................................................................................................222 Paclitaxel Technology - Cardiovascular.........................................................................................222 Portable Ultrasonic Nebulizer - Cardiovascular Disease................................................................223 Pro-Apolipoprotein A-I - Cardiovascular.......................................................................................224 Essential Benchmarks for Dealmaking 7
  • 6. Table of Contents Ranexa - Angina.............................................................................................................................225 . Relovair - Chronic Obstructive Pulmonary Disease and Asthma...................................................228 RNAi Technologies - Respiratory Syncytial Virus.........................................................................230 Tadalafil - Hypertension. ................................................................................................................232 . Teveten - Hypertension...................................................................................................................236 ThromboClear - Cardiovascular.....................................................................................................237 Tiazac - To Reduce the Risk of Heart Attacks................................................................................238 Central Nervous System...............................................................................................................239 Acurox - Abuse-Resistant Painkiller. .............................................................................................240 . ALKS 33 - Alcohol Dependence....................................................................................................241 Alzheimer’s Drug - Alzheimer’s Disease.......................................................................................243 Alzheimer’s Drug - Alzheimer’s Disease.......................................................................................244 Alzheimer’s Drug - Alzheimer’s Disease.......................................................................................246 Alzheimer’s Drug - Alzheimer’s Disease.......................................................................................247 Ampligen - Chronic Fatigue Syndrome..........................................................................................248 Attention Deficit Hyperactivity Disorder Therapy.........................................................................250 Avinza - Pain...................................................................................................................................251 Avinza - Pain...................................................................................................................................253 Axokine/Pegylated Axokine - Obesity...........................................................................................255 . AZ-004 - Schizophrenia or Bipolar Disorder.................................................................................256 Bicifadine - Dental Pain..................................................................................................................258 Brain-Derived Neurotrophic Factor................................................................................................261 Chronogesic - Pain..........................................................................................................................264 Dexfenfluramine - Obesity. ............................................................................................................265 . Doxylamine Succinate Nasal Spray - Sleep Therapy.....................................................................267 Entereg - Pain.................................................................................................................................269 . Estradot - Menopausal Symptoms..................................................................................................270 Fanapt - Schizophrenia...................................................................................................................272 Fanapt - Schizophrenia...................................................................................................................273 Fanapt - Schizophrenia...................................................................................................................274 Flexogan - Pain Management.........................................................................................................276 Frova - Menstrual Migraines..........................................................................................................277 Frova - Migraine Relief..................................................................................................................279 Gralise - Postherpetic Neuralgia.....................................................................................................281 Horizant - Pain................................................................................................................................282 Indiplon - Insomnia.........................................................................................................................284 Indiplon - Insomnia.........................................................................................................................287 Inflammation Antibody-based Therapeutics...................................................................................289 Ion Channel Modulators - Pain.......................................................................................................291 Ketoprofen - Inflammation.............................................................................................................292 Memryte - Alzheimer’s Disease.....................................................................................................293 . Memryte - Alzheimer’s Disease.....................................................................................................295 . Naked DNA Technology.................................................................................................................297 Neotrofin - Neuroimunologic Disorders.........................................................................................299 Nervous System Therapeutics........................................................................................................302 . 8 BioWorld Data: Biopharmaceutical Royalty Rates Analysis
  • 7. Table of Contents NeuroCell - Parkinson’s and Huntington’s diseases.......................................................................304 Neuroimmunophilins - Nerve Repair.............................................................................................307 . Neurological Peptide Therapy........................................................................................................309 Neurological Therapeutics.............................................................................................................. 311 NGD 94-1 - Schizophrenia.............................................................................................................312 NicVAX - Smoking Cessation........................................................................................................313 Novantrone - Multiple Sclerosis.....................................................................................................316 NRP104 - Attention Deficit Hyperactivity Disorder. .....................................................................320 . Opana - Pain...................................................................................................................................323 . Oral Flupirtine - Fibromyalgia........................................................................................................325 Oruvail - Pain..................................................................................................................................326 Pain Management...........................................................................................................................327 . Phospholipids - Central Nervous System Conditions.....................................................................328 Posidur - Postsurgical Pain.............................................................................................................329 PQ-1002 - Anesthesia.....................................................................................................................331 Remoxy - Pain................................................................................................................................332 . Risperdal Consta - Schizophrenia and Bipolar Disorder................................................................333 Ryzolt - Pain...................................................................................................................................335 . Sarafem - Premenstrual Syndrome.................................................................................................336 Transgenic Mouse Model - Alzheimer’s Disease...........................................................................340 Treximet - Migraine........................................................................................................................341 Vivitrol - Alcohol & Opioid Dependency.......................................................................................343 Zolpimist - Insomnia.......................................................................................................................345 Diabetes.......................................................................................................................................... 347 A-4166 - Diabetes...........................................................................................................................348 AERx - Diabetes.............................................................................................................................349 AGT 203 - Cancer, Age-Related Degeneration, Diabetes, Obesity................................................350 Bydureon - Diabetes.......................................................................................................................351 Bydureon - Type II Diabetes...........................................................................................................353 Development of Drugs - Type II Diabetes......................................................................................355 Diabetes Therapy............................................................................................................................356 Diabetes Therapy............................................................................................................................358 Fortamet - Type II Diabetes............................................................................................................359 Glumetza - Diabetes. ......................................................................................................................360 . Luteolin - Diabetes. ........................................................................................................................361 . SF-1019 - Diabetes.........................................................................................................................362 Infection......................................................................................................................................... 363 Alpha Interferon-Natural - Infection. .............................................................................................364 . Alferon N Injection - Viral Diseases...............................................................................................367 AmBisome - Fungal Infections.......................................................................................................371 Antibody IFT - HIV........................................................................................................................372 BioNasal - Chronic Rhinosinusitis.................................................................................................373 BPI - Sepsis.....................................................................................................................................375 CY 1787 and CY 1503 - Septic Shock and Adult Respiratory Distress Syndrome........................379 Danoprevir (RG7227) - Hepatitis C. ..............................................................................................380 . Essential Benchmarks for Dealmaking 9
  • 8. Table of Contents Erythromycin Antibiotic - Bacterial Infections..............................................................................383 . Fuzeon - HIV..................................................................................................................................384 Gene Therapy Products - Hepatitis B and C...................................................................................386 HE317 - Immunodeficiencies.........................................................................................................387 Hepatitis and Retrovirus Technologies - Hepatitis G.....................................................................388 . Hepatitis A Vaccine.........................................................................................................................389 Hepatitis B Drug - Infection...........................................................................................................390 Hepatitis B Drug.............................................................................................................................391 Hepatitis C Vaccine.........................................................................................................................392 Hepatitis E Vaccine.........................................................................................................................393 HepeX-B - Hepatitis B....................................................................................................................394 Heplisav - Infection........................................................................................................................395 . HIV and Hepatitis Vaccines............................................................................................................396 HIV/AIDS Vaccine.........................................................................................................................398 HIV Drug........................................................................................................................................402 HIV Drugs. .....................................................................................................................................403 . Iminosugars - Potential Antiviral....................................................................................................405 Incivek - Hepatitis C.......................................................................................................................406 Infergen - Hepatitis C.....................................................................................................................408 . Interferon-g - HIV...........................................................................................................................412 Method for Interferon - Hepatitis B and C infection......................................................................414 Monoclonal Antibodies - Gram-Negative Sepsis-Related Bacteria...............................................416 . Naked DNA Technology.................................................................................................................419 Nanocrystalline Particles................................................................................................................421 NCX 1000 - Hepatitis C and Hypertension....................................................................................422 Novasome Lipid Vesicles Encapsulation Technology - Vaccines...................................................424 Omniferon - Hepatitis C.................................................................................................................425 . Oragen - HIV..................................................................................................................................428 Protease Inhibitors - HIV and AIDS...............................................................................................430 Questcor Patents – Hepatitis C.......................................................................................................432 Relenza - Influenza.........................................................................................................................434 Ribozymes - HIV............................................................................................................................436 S-1153 - HIV...................................................................................................................................438 Small Molecules - Hepatitis C........................................................................................................440 Tamiflu - Influenza..........................................................................................................................442 Taribavirin - Hepatitis C.................................................................................................................445 Technologies and Product Candidates - Hepatitis C.......................................................................448 Tyzeka/Sebivo - Hepatitis B...........................................................................................................449 Vaccines, Gene-Based - HIV, Hepatitis B & C Viruses, Herpes, . .................................................451 Papilloma, Measles, Tuberculosis and Influenza............................................................................451 Vaccine Research - HIV, Hepatitis, Influenza.................................................................................453 Vibativ - Gram-Positive Infections.................................................................................................454 Viread - HIV...................................................................................................................................455 Viread and Preveon - HIV..............................................................................................................458 . Virus-like Particle Vaccines - Human Papillomavirus....................................................................462 Zadaxin - Hepatitis C......................................................................................................................464 10 BioWorld Data: Biopharmaceutical Royalty Rates Analysis
  • 9. Table of Contents Miscellaneous................................................................................................................................ 466 . A1PI - Alpha-1 antitrypsin deficiency............................................................................................467 Actimmune - Infections, Pulmonary Fibrosis and Cancer..............................................................469 Aldurazyme - Mucopolysaccharidosis I.........................................................................................471 Alpha Interferon..............................................................................................................................473 Auriculin Anaritide - Acute Renal Failure......................................................................................475 Bio-Equivalent Cardizem CD ........................................................................................................477 Cochleates, Liposomes and Proteoliposomes.................................................................................478 Collagenase Ointment - Dermal Ulcers and Burns.........................................................................484 Combinatorial Chemistry Services - Drug Discovery....................................................................485 CY 1787 and CY 1503 - Septic Shock and Adult Respiratory Distress Syndrome........................486 Cytofectins - Cystic Fibrosis..........................................................................................................488 . Dermagran II Ointment and Spray - Wound Healing.....................................................................490 Estrasorb - Estrogen Therapy.........................................................................................................491 . Gattex - Gastrointestinal Disorders. ...............................................................................................494 . Gene Therapy Partnership Network...............................................................................................496 . Gene Therapy Treatments...............................................................................................................497 Genentech Products........................................................................................................................499 Hectorol - Osteoporosis..................................................................................................................504 Hextend and PentaLyte - Hypovolemia..........................................................................................507 Hextend and PentaLyte - Hypovolemia..........................................................................................509 Hextend - Hypovolemia.................................................................................................................. 511 Hextend - Hypovolemia..................................................................................................................513 Human Growth Hormone...............................................................................................................515 Humanized Antibody......................................................................................................................516 IgA Nephropathy Treatment...........................................................................................................518 IMOs - Allergy................................................................................................................................520 Indaflex and Flexogan - Inflammatory. ..........................................................................................522 . Kuvan, PEG-PAL, 6R-BH4 - Phenylketonuria and Cardiovascular. .............................................524 . Living Cells Connective Tissue......................................................................................................526 Loteprednol Etabonate - Ophthalmic..............................................................................................527 Lubrin - Vaginal Dryness................................................................................................................528 M-Enoxaparin.................................................................................................................................529 MDX-RA - Secondary Cataracts....................................................................................................530 Monoclonal Antibodies Binding to TGF-B....................................................................................534 Neupogen - Anemia........................................................................................................................536 Oral Contraceptives........................................................................................................................539 Prochieve - Preterm Birth...............................................................................................................540 Procrit - Anemia..............................................................................................................................541 Receptor-Mediated Permeabilizers.................................................................................................545 RNA Interference Technology........................................................................................................547 RNA Interference Technology........................................................................................................550 Sexual Dysfunction Therapy..........................................................................................................554 . Solaraze and Others - Dermatology................................................................................................555 Systemic Evolution of Ligands through EXponential Enrichment (SELEX) - Oligonucleotides Screening Process...........................................................................................................................557 TGF-beta - Ophthalmological, Wounds, Autoimmune...................................................................560 Essential Benchmarks for Dealmaking 11
  • 10. Table of Contents Thymosin Beta 4 - Various Indications. .........................................................................................565 . Vaniqa - Excessive Facial Hair on Women.....................................................................................567 Technology..................................................................................................................................... 570 ACTCellerate - Embryonic Stem Cell Technology........................................................................571 Bioadhesive Delivery System - Drug Delivery..............................................................................573 Cell Culture Flask Patent................................................................................................................574 Cochleate Technology.....................................................................................................................576 Cypress Stem Cells.........................................................................................................................580 DNA Nanocircles - Research..........................................................................................................581 Duros Drug Delivery Technology...................................................................................................582 Gene Alteration Technology...........................................................................................................585 Gene Sequencing Technology - Infectious Diseases......................................................................586 Genetically Engineered Listeria Immune Therapy.........................................................................588 Heat-Activated Gene Therapy Technology - Cancer......................................................................591 hESC Technology - Technology.....................................................................................................593 HuMAb-Mouse Technology...........................................................................................................595 Mammalian Embryonic Stem Cells Technology............................................................................599 Method for Binding DNA and RNA...............................................................................................601 Naked DNA Technology.................................................................................................................602 NASA Technology..........................................................................................................................604 Natural Cell Signaling Technologies..............................................................................................605 Nebulizer - Technology. .................................................................................................................607 . NTP Testing Technology - Technology..........................................................................................608 . Nucleoside Technology - Hepatitis B.............................................................................................609 Optison - Contrast Agent................................................................................................................610 PharmaPrint Process - Drug Development, Botanicals..................................................................612 ppGpp Degradase and Peptide Deformylase Technology..............................................................613 . Stem Cell Lines...............................................................................................................................614 Stem Cell Technology.....................................................................................................................615 Stem-Loop Vector Technology ......................................................................................................616 Thrombus Ligands - Diagnostic Imaging.......................................................................................617 Thymidine Kinase Isoenzyme Diagnostics and Thymidine Kinase Hybridomas..........................619 UMASS Patents - Cartilage Regenerative Technology..................................................................620 VelocImmune Technology..............................................................................................................621 XenoMouse Technology - Cancer..................................................................................................623 . Indices............................................................................................................................................ 624 Companies and Other Organizations Index....................................................................................625 Inventors Index...............................................................................................................................631 Drugs and Therapeutic Technologies Index...................................................................................632 . Diseases, Indications and Targets Index.........................................................................................636 12 BioWorld Data: Biopharmaceutical Royalty Rates Analysis
  • 11. Cancer Picoplatin - Small-Cell Lung Cancer Licensor Genzyme Corp. Licensee Poniard Pharmaceuticals Inc. Royalty/Deal Value $11 million cash plus $1 million of common stock plus 9% of sales Drug/Product Name Picoplatin Type/Product Area License agreement for worldwide rights Terms/Details $11 million cash plus $1 million of common stock plus 9% of sales Date 2004 Deal Summary Poniard holds an exclusive worldwide license granted from Genzyme Corp. for the development and commercial sale of picoplatin. Under the license agreement, as amended, Genzyme retains the right to prosecute its patent ap- plications and maintain all licensed patents, with Poniard reimbursing such expenses. Poniard has the right to sue any third party infringers of the picoplatin patents. If Poniard does not file suit, Genzyme, in its sole discretion, has the right to sue the infringer at its expense. The parties executed the license agreement in April 2004, at which time Poniard paid a one-time upfront mile- stone payment of $1 million in common stock and $1 million in cash. The original license agreement excluded Japan from the licensed territory and provided for $13 million in development and commercialization milestones, payable in cash or a combination of cash and common stock, and a royalty rate of up to 15% of product net sales after regulatory approval. The parties amended the license agreement on Sept. 18, 2006, modifying several key financial terms and expanded the licensed territory to include Japan, thereby providing Poniard worldwide rights. In consideration of the amendment, Poniard paid Genzyme $5 million in cash on Oct. 12, 2006 and paid Genzyme an additional $5 million in cash on March 30, 2007. The amendment eliminated all development milestone pay- ments to Genzyme. Poniard remains obligated to pay a total of $5 million in commercialization milestones upon the attainment of certain levels of annual net sales of picoplatin after regulatory approval. The amendment also reduced the royalty payable to Genzyme to a maximum of 9% of annual net product sales and eliminated sharing of sublicense revenues with Genzyme. The license agreement may be terminated by either party for breach, or if the other party files a petition in bankruptcy or insolvency or for reorganization or is dissolved, liquidated or makes assignment for the benefit of creditors. Poniard can terminate the license at any time upon prior written notice to Genzyme. If not earlier terminated, the license agreement will continue in effect, in each country in the territory in which the licensed product is sold or manufactured, until the earlier of (i) expiration of the last valid claim of a pending or issued patent covering the licensed product in that country or (ii) a specified number of years after first commercial sale of the licensed product in that country. Poniard’s picoplatin portfolio includes U.S. and foreign patents and applications licensed from Genzyme, which cover the picoplatin product. With respect to picoplatin, Poniard expected to rely primarily on U.S. Patent No. 5,665,771 (expiring Feb. 7, 2016), which is licensed to it by Genzyme, and additional licensed patents expiring in 2016 covering picoplatin in the European Union and other countries. 148 BioWorld Data: Biopharmaceutical Royalty Rates Analysis
  • 12. Cancer Picoplatin Drug Description/ Picoplatin is an intravenous platinum-based chemotherapeutic designed to treat sol- Mechanism id tumors that are resistant to existing platinum-based cancer therapies. Drug History The FDA designated picoplatin as an orphan drug for the treatment of small cell lung cancer and the European Commission designated picoplatin as an orphan medicinal product for the treatment of small cell lung cancer in the European Union, which en- titles Poniard to exclusive marketing rights for picoplatin in the European Union for ten years following market approval. In 2010, Poniard decided to suspend efforts to obtain regulatory approval of pico- platin after a detailed analysis primary and updated data from the Phase III study of picoplatin in small-cell lung cancer (SCLC) and an evaluation of the ongoing new drug application process with the FDA. The company said it has engaged Leerink Swann LLC to conduct a comprehensive review of strategic alternatives, which could include capital raising alternatives, merger, sale or partnership. Poniard also announced a re- structuring of its work force, eliminating about 45%, to a total of 12, effective April 30. The company said it would focus its resources on developing pivotal clinical strate- gies for picoplatin in small-cell lung cancer, as well as colorectal, prostate and ovarian cancers. Poniard executives blamed the failure of the highly anticipated SPEAR (Study of Pico- platin Efficacy After Relapse) trial on an imbalance of third-line chemotherapy given to patients in the best supportive care arm vs. the picoplatin arm. Genzyme Corp. Company Founded in June 1981 by Henry Blair and Sherry Snyder History Began operations by acquiring Whatman Biochemicals Ltd., UK Member--Biotechnology Industry Organization Founded 16 labs (1990) Formed Neozyme Corp. to fund development of programs (10/90) Formed Neozyme II to fund the research, development and clinical testing of biotherapeutic products for the treatment of cystic fibrosis (4/92) Subsidiary IG Laboratories Inc. purchased Genetic Design Inc., a privately held genetic testing company (6/92) Acquired phospholipid business of Enzymatix Ltd. (6/92) Acquired Medix Biotech Inc. (6/92) Acquired Vivigen Inc., in exchange for stock valued at $40M (11/92) Neozyme I buyback of four programs, $49M (12/92) Established Genzyme Transgenics (now GTC Biotherapeutics) for producing human biothera- peutic products in the milk of transgenic animals (2/93) Acquired diagnostic business Virotech System-Diagnostika GmbH (4/93) Acquired diagnostic business Omnia Res srl (5/93) Neozyme I buyback of two programs, $49M (12/93) Acquired Swiss pharmaceutical manufacturer, Sygena Ltd. (7/94) Subsidiary Genzyme Transgenics purchased TSI, a publicly held clinical testing and production company (10/94) Essential Benchmarks for Dealmaking 149
  • 13. Cancer Created Genzyme Tissue Repair by acquiring BioSurface Technology Inc. and combining with several of Genzyme Corp.’s tissue repair programs (12/94) Acquired all shares of IG Laboratories Inc. (9/95) Formed Aristogen GmbH with Symbiomed (Germany) to offer genetic diagnostic services in Germany (3/96) Acquired Genetrix Inc. (4/96) Acquired Deknatel Snowden Pencer Inc., $250M (7/96) Neozyme II Corp. buyback, $109M (9/96) Formed Genzyme Molecular Oncology Division after acquisition of PharmaGenics Inc. (6/97) Acquired ABIOMED Inc. for $15M (7/97) Sold research products business to Techne Corp. for $65.5M (6/98) Acquired GelTex Pharmaceuticals Inc. (12/00) Acquired Novazyme Pharmaceuticals (9/01) Ceased trading of Genzyme Biosurgery and Genzyme Molecular Oncology stock (7/03) Acquired Sangstat Medical Corp. (12/03) Acquired ILEX Oncology Inc. (12/04) Acquired Verigen AG (2/05) Acquired Bone Care International (7/05) Acquired AAV gene therapy assets from Avigen Inc. (12/05) Acquired AnorMED Inc. (11/06) Acquired manufacturing equipment and other technology from Targeted Genetics Corp. for up to $7M (2/10) Sold Genzyme Genetics to Laboratory Corp. of America for $925M (9/10) Sold its diagnostic products business to Sekisui Chemical Co. Ltd. For $265M (11/10) Sold its enetics business unit to Laboratory Corp. of America (11/10) Sold its pharmaceutical intermediates business to International Chemical Investors Group (3/11) Acquired by Sanofi-Aventis SA (4/11) Genzyme Corp.: Additional Agreements Partnered Company Products Involved Agreement Type Date Algeta ASA to study cancer targets using its Thorium plat- partnership 4/11 form and Genzyme's tumor-targeting antibody Angiotech Pharmaceu- identification, development and commercializa- strategic collab- 5/06 ticals Inc. tion of therapies for cancer patients undergoing oration agree- surgical removal of tumors ment Arecor Ltd. development of stable, high-strength formula- collaboration 4/10 tions of labile biomolecules De Novo Pharmaceuti- De Novo to apply its molecular structure gen- drug discovery 1/06 cals Ltd. erating technology to focus on a disease target c o l l a b o r a t i o n that is of interest to Genzyme agreement ERYtech Pharma therapeutic enzyme formulation for Genzyme d e v e l o p m e n t 10/10 disease indications using technology developed agreement by ERYtech 150 BioWorld Data: Biopharmaceutical Royalty Rates Analysis
  • 14. Cancer Hospira Worldwide Inc. to perform fill and finish manufacturing services material defini- 1/10 for Genzyme's Cerezyme, Fabrazyme, Myozyme tive agreement and Thyrogen Isis Pharmaceuticals mipomersen licensing and 6/08 collaboration agreement Moffitt Cancer Center diagnostic testing rights for two proteins for licensing agree- 1/08 NSCLC ment Oswaldo Cruz Founda- focus on neglected diseases, initially Chagas dis- research collabo- 7/07 tion ease ration PTC Therapeutics Inc. PTC124 global develop- 7/08 ment and com- mercialization agreement, rights returned to PTC (9/11) To-BBB Technologies BV evaluation of G-Technology research collabo- 11/09 ration Veracyte Inc. Veracyte's Afirma Thyroid FNA Analysis diagnos- global promo- 1/12 tic for thyroid cancer tion agreement Essential Benchmarks for Dealmaking 151
  • 15. Infection HepeX-B - Hepatitis B Licensor XTL Biopharmaceuticals Ltd. Licensee Cubist Pharmaceuticals Inc. Royalty/Deal Value $5 million plus 10% to 17% of sales Drug/Product Name HepeX-B Type/Product Area Cubist licensed worldwide rights to develop and commercialize the monoclonal anti- body for hepatitis B Terms/Details XTL got $3 million in collaboration support and up-front payments and would be entitled to another $3 million in milestones, plus royalties Date June 2004 Deal Summary In June 2004, XTL granted worldwide rights to Cubist for the development and commercialization of an inves- tigational monoclonal antibody known as HepeX-B, then in Phase IIb testing for the prevention of re-infection by the hepatitis B virus in liver transplant patients. The companies agreed to continue the ongoing study and, if successful, move into late-stage development. Cubist agreed to fund HepeX-B’s development costs and would be responsible for worldwide registration and commercialization. It agreed to pay XTL collaboration support and up-front payments totaling $3 million over the first two years and would owe an additional $3 million upon the achievement of certain regulatory milestones. Cubist also committed to pay XTL a tiered royalty, ranging from 10% to 17% of net sales. HepeX-B Drug Description/ The drug is an antibody product designed to prevent re-infection by the hepatitis B Mechanism virus in liver transplant patients. Drug History HepeX-B demonstrated positive results in a Phase IIb study; however, meetings with the FDA indicated that the regulatory pathway for the drug would pose operational and economic challenges, and the companies decided to stop investing in the part- nership in 2006. XTL Biopharmaceuticals Ltd. Company Founded in 1993 History Business Development, in-licensing, acquisition and commercialization of proprietary products and Strategy late-stage pharmaceutical product candidates for the treatment of unmet medical needs 394 BioWorld Data: Biopharmaceutical Royalty Rates Analysis